scholarly journals Early combined immunosuppression may be effective and safe in older patients with Crohn’s disease: post hoc analysis of REACT

2019 ◽  
Vol 49 (9) ◽  
pp. 1188-1194 ◽  
Author(s):  
Siddharth Singh ◽  
Larry W. Stitt ◽  
Guangyong Zou ◽  
Reena Khanna ◽  
Parambir S. Dulai ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Older Patients ◽  
Post Hoc Analysis ◽  
Post Hoc

Outcomes of Passable and Non-passable Strictures in Clinical Trials of Crohn’s Disease: A Post-hoc Analysis

2021 ◽  
Author(s):  
Neeraj Narula ◽  
Emily C L Wong ◽  
Parambir S Dulai ◽  
John K Marshall ◽  
Jean-Frederic Colombel ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Activity Index ◽  
Disease Activity Index ◽  
Symptom Improvement ◽  
Logistic Regression Models ◽  
Post Hoc Analysis ◽  
Endoscopic Remission ◽  
Post Hoc ◽  
The Impact

Abstract Background and Aims There is paucity of evidence on the reversibility of Crohn’s disease [CD]-related strictures treated with therapies. We aimed to describe the clinical and endoscopic outcomes of CD patients with non-passable strictures. Methods This was a post-hoc analysis of three large CD clinical trial programmes examining outcomes with infliximab, ustekinumab, and azathioprine, which included data on 576 patients including 105 with non-passable strictures and 45 with passable strictures, as measured using the Simple Endoscopic Score for Crohn’s Disease [SES-CD]. The impact of non-passable strictures on achieving clinical remission [CR] and endoscopic remission [ER] was assessed using multivariate logistic regression models. CR was defined as a Crohn’s Disease Activity Index [CDAI] <150, clinical response as a CDAI reduction of ≥100 points, and ER as SES-CD score <3. Results After 1 year of treatment, patients with non-passable strictures demonstrated the ability to achieve passable or no strictures in 62.5% of cases, with 52.4% and 37.5% attaining CR and ER, respectively. However, patients with non-passable strictures at baseline were less likely to demonstrate symptom improvement compared with those with passable or no strictures, with reduced odds of 1-year CR (adjusted odds ratio [aOR] 0.17, 95% CI 0.03–0.99, p = 0.048). No significant differences were observed between patients with non-passable strictures at baseline and those with passable or no strictures in rates of ER [aOR 0.82, 95% CI 0.23–2.85, p = 0.751] at 1 year. Conclusions Patients with non-passable strictures can achieve symptomatic and endoscopic remission when receiving therapies used to treat CD, although they are less likely to obtain CR compared with patients without non-passable strictures. These findings support the importance of balancing the presence of non-passable strictures in trial arms.

scholarly journals DOP019 Effect of vedolizumab treatment on extraintestinal manifestations in patients with Crohn’s disease: a GEMINI 2 post hoc analysis

2017 ◽  
Vol 11 (suppl_1) ◽  
pp. S36-S38
Author(s):  
B.G. Feagan ◽  
W.J. Sandborn ◽  
J.-F. Colombel ◽  
S. O’Byrne ◽  
J.M. Khalid ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Extraintestinal Manifestations ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals Association of Biomarker Cutoffs and Endoscopic Outcomes in Crohn’s Disease: A Post Hoc Analysis From the CALM Study

2020 ◽  
Vol 26 (10) ◽  
pp. 1562-1571 ◽  
Author(s):  
Walter Reinisch ◽  
Remo Panaccione ◽  
Peter Bossuyt ◽  
Filip Baert ◽  
Alessandro Armuzzi ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Surrogate Marker ◽  
Fecal Calprotectin ◽  
Sensitivity Analyses ◽  
End Points ◽  
Predictive Values ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
Disease Location

Abstract Background CALM was a randomized phase 3 trial in patients with Crohn’s disease (CD) that demonstrated improved endoscopic outcomes when treatment was escalated based on cutoffs for inflammatory biomarkers, fecal calprotectin (FC), C-reactive protein (CRP), and CD Activity Index (CDAI) remission vs CDAI response alone. The purpose of this post hoc analysis of CALM was to identify drivers of treatment escalation and evaluate the association between biomarker cutoff concentrations and endoscopic end points. Methods The proportion of patients achieving CD Endoscopic Index of Severity (CDEIS) <4 and no deep ulcers 48 weeks after randomization was evaluated according to CRP <5 mg/L or ≥5 mg/L and FC <250 μg/g or ≥250 μg/g. Subgroup analyses were performed according to disease location, and sensitivity analyses were conducted in patients with elevated CRP and/or FC at baseline. The association between endoscopic end points and biomarker cutoffs was performed using χ 2 test. Results The proportion of patients who achieved the primary end point CDEIS <4 and no deep ulcers was significantly greater for those with FC <250 µg/g (74%; P < 0.001), with an additive effect for CRP <5 mg/L. The association of FC <250 µg/g with improved endoscopic outcomes was independent of disease location, although the greatest association was observed for ileocolonic disease. Fecal calprotectin <250 µg/g, CRP <5 mg/L, and CDAI <150 gave a sensitivity/specificity of 72%/63% and positive/negative predictive values of 86%/42% for CDEIS <4 and no deep ulcers 48 weeks after randomization. Conclusion This post hoc analysis of CALM demonstrated that a cutoff of FC <250 µg/g is a useful surrogate marker for mucosal healing in CD.

14 POST-HOC ANALYSIS OF TOFACITINIB CROHN’S DISEASE PHASE 2 INDUCTION EFFICACY IN SUBGROUPS WITH BASELINE ENDOSCOPIC OR BIOMARKER EVIDENCE OF INFLAMMATION

2018 ◽  
Vol 154 (1) ◽  
pp. S81 ◽  
Author(s):  
Bruce E. Sands ◽  
Julian Panés ◽  
Peter D.R. Higgins ◽  
Michele Moscariello ◽  
Gary Chan ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Phase 2 ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals Evolution of Endoscopic Activity Scores in Patients With Crohn's Disease Under Azathioprine and/or Infliximab: A Post-Hoc Analysis of the Sonic Data

2011 ◽  
Vol 140 (5) ◽  
pp. S-422 ◽  
Author(s):  
Marc Ferrante ◽  
Jean-Frederic Colombel ◽  
William J. Sandborn ◽  
Walter Reinisch ◽  
Gerassimos J. Mantzaris ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Post Hoc Analysis ◽  
Post Hoc

Tu1726 – The Impact of Early Disease Control with Vedolizumab on Surgery Rates Among Patients with Crohn's Disease: A Post Hoc Analysis of the Gemini Trials

2019 ◽  
Vol 156 (6) ◽  
pp. S-1100
Author(s):  
Parambir S. Dulai ◽  
Laurent Peyrin-Biroulet ◽  
Kristen Hahn ◽  
Natasha Khalife ◽  
Dirk Lindner ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Disease Control ◽  
Early Disease ◽  
Post Hoc Analysis ◽  
Surgery Rates ◽  
Post Hoc ◽  
The Impact

Sa1772 - Sustained Clinical Remission with Vedolizumab in Moderateto-Severe Crohn's Disease: A Gemini 2 Post HOC Analysis of Week 14 Remitters

2018 ◽  
Vol 154 (6) ◽  
pp. S-389
Author(s):  
Robert Hardi ◽  
Bernd Bokemeyer ◽  
William J. Sandborn ◽  
Walter Reinisch ◽  
Ira Shafran ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Remission ◽  
Post Hoc Analysis ◽  
Post Hoc

Week 6 Calprotectin Best Predicts Likelihood of Long-term Endoscopic Healing in Crohn’s Disease: A Post-hoc Analysis of the UNITI/IM-UNITI Trials

2020 ◽  
Author(s):  
Neeraj Narula ◽  
Emily C L Wong ◽  
Parambir S Dulai ◽  
John K Marshall ◽  
Jean-Frederic Colombel ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Predictive Performance ◽  
Drug Level ◽  
Symptom Improvement ◽  
Faecal Calprotectin ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
The Relationship

Abstract Objectives There is need for biomarkers as predictors of outcome of medical treatment in Crohn’s disease. The purpose of this study was to evaluate the predictive performance of faecal calprotectin for short- and long-term clinical and endoscopic outcomes. Methods This post-hoc analysis of the UNITI/IM-UNITI studies [NCT01369329, NCT01369342, and NCT01369355; YODA #2019–4026] included 677 patients to evaluate the relationship of Week 6 calprotectin cut-offs and changes from baseline assessments in calprotectin for prediction of outcomes at Weeks 8, 32, and 52, using receiver operating characteristic curves with comparisons of areas under the curve [AUC]. The relationship between clinical and biomarker assessments at Week 6 and endoscopic remission [ER] at Week 52 was evaluated using multivariate logistic regression models adjusted for confounders. Results A Week 6 calprotectin <250 mg/kg demonstrated a significant ability to predict Week 52 ER (AUC 0.709, 95% confidence interval [CI] 0.566–0.852, p = 0.014) with fair accuracy, and performed better than other calprotectin cut-offs and deltas from baseline for prediction of Week 52 ER. When adjusted for covariates, patients with a Week 6 faecal calprotectin <250 mg/kg had 3.48 times [95% CI 1.31–9.28, p = 0.013] increased odds of Week 52 ER. No other Week 6 clinical assessment [clinical remission or clinical response] or biomarker [CRP <5 or drug level] had an association with Week 52 ER. Conclusions In summary, the results of this post-hoc analysis suggest that Week 6 calprotectin levels < 250 mg/kg can be predictive of future endoscopic healing and may be more informative than clinical symptom improvement. Podcast This article has an associated podcast which can be accessed at https://academic.oup.com/ecco-jcc/pages/podcast

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